Cancer Immunotherapy Programme, Malaghan Institute of Medical Research, Wellington, New Zealand; Wellington Blood & Cancer Centre, Capital & Coast District Health Board, Wellington, New Zealand; Department of Pathology & Molecular Medicine, University of Otago Wellington, Wellington, New Zealand.
Cancer Immunotherapy Programme, Malaghan Institute of Medical Research, Wellington, New Zealand; Wellington Blood & Cancer Centre, Capital & Coast District Health Board, Wellington, New Zealand.
N Z Med J. 2021 Sep 17;134(1542):96-108.
Chimeric antigen receptor (CAR) T-cells are a personalised cell and gene therapy for cancer that are becoming an international standard of care for some refractory B-cell leukaemias, non-Hodgkin lymphomas and myeloma. A single CAR T-cell administration can result in durable complete response for some recipients. Domestic CAR T-cell manufacturing capability was established for Aotearoa New Zealand's first CAR T-cell trial (ENABLE, ClinicalTrials.gov NCT04049513). This article outlines CAR T-cell manufacturing and logistical considerations, with a focus on New Zealand's environment for this personalised cell and gene therapy. We discuss Māori engagement in CAR T-cell trial and clinical service design, and propose enhancing Māori guardianship (kaitiakitanga) over cells and genetic material through on-shore manufacture. Strategies to safely deliver CAR T-cells within New Zealand's healthcare system are outlined. Finally, we discuss challenges to, and opportunities for, widening CAR T-cell availability and assuring equity of access. Based on our experience, we consider Aotearoa New Zealand to be in an excellent position to develop and implement investigational and commercial CAR T-cell therapies in the future.
嵌合抗原受体 (CAR) T 细胞是一种癌症的个体化细胞和基因治疗方法,已成为某些难治性 B 细胞白血病、非霍奇金淋巴瘤和骨髓瘤的国际标准治疗方法。对于一些接受者来说,单次 CAR T 细胞给药可导致持久的完全缓解。奥塔哥新西兰的第一个 CAR T 细胞试验(ENABLE,ClinicalTrials.gov NCT04049513)建立了国内的 CAR T 细胞制造能力。本文概述了 CAR T 细胞的制造和后勤方面的考虑因素,重点是新西兰在这种个体化细胞和基因治疗方面的环境。我们讨论了毛利人在 CAR T 细胞试验和临床服务设计中的参与,并提出通过在岸制造来增强对细胞和遗传物质的毛利监护(kaitiakitanga)。概述了在新西兰的医疗保健系统内安全输送 CAR T 细胞的策略。最后,我们讨论了扩大 CAR T 细胞可用性和确保公平获得机会的挑战和机遇。基于我们的经验,我们认为新西兰奥塔哥在未来开发和实施研究性和商业 CAR T 细胞疗法方面处于极佳地位。
N Z Med J. 2021-9-17
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